CRO Oversight - US edition MasterClass

This online training provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting. It also includes information about the global regulatory landscape regarding CRO management, primarily focusing on EMA, FDA, and ICH E6(R2).

26-27 July, 2023 , Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

This is a topic that is important to all Sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product development. Sponsors outsource for many reasons, including but not limited to, meeting the temporary need for a large expanded workforce, additional and sometimes unique expertise, technology, and quality systems. To make these partnerships work, Sponsors must have systems in place to oversee the quality of the CRO’s work for the protection of study participants and also the reliability of the data. The training provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting. It also includes information about the global regulatory landscape regarding CRO management, primarily focusing on EMA, FDA, and ICH E6(R2).

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RECOMMENDATION

Who should attend?

This course is designed for clinical research personnel who are involved in the selection, oversight, and management of CROs and other vendors. It is ideal for sponsor clinical trial leaders, clinical project managers, and others involved in decision-making regarding vendors.